Abbott Announces Results Of Analysis Exploring The Use Of HUMIRA® (Adalimumab) In Simultaneously Achieving Three Key Treatment Goals For Rheumatoid Arthritis

According to treatment guidelines from the ACR and the European League Against Rheumatism (EULAR), the primary target of RA treatment should be clinical remission, defined as the absence of signs and symptoms of significant inflammatory disease activity. For patients with long-standing disease, ACR and EULAR recommend low disease activity as an appropriate alternative measure.

"In recent years, we have been discussing the need for a broader approach to treatment —such as in addition to measuring disease activity, measuring structural changes and functional impairment —which may help physicians and patients mitigate further irreversible effects of the disease," said Dr. Edward Keystone, Professor of Medicine, University of Toronto, Canada. "This analysis evaluates whether or not this is a realistic treatment goal for RA patients, and sheds light on HUMIRA's potential to help patients simultaneously achieve all three key treatment goals. It also supports that the response rates are likely to be higher in patients diagnosed and treated earlier."

All studies in this analysis–DE019, OPTIMA and PREMIER–included a comparison of the use of HUMIRA plus MTX versus placebo plus MTX. The results are based on a post-hoc analysis and are hypothesis-generating only.

"Advances in the last decade offer new treatment options to better manage RA, including reducing signs and symptoms, improving physical function and inhibiting progression of further joint damage," said John R. Medich, Ph.D., divisional vice president, Immunology Clinical Development, Global Pharmaceutical Research and Development, Abbott. "We believe that the potential effects of RA need to be addressed in a comprehensive manner that addresses not only symptom improvement but also other important treatment goals. Through 15 years of clinical experience and ongoing HUMIRA studies, Abbott is committed to this effort."

About Rheumatoid ArthritisRA is a chronic inflammatory disease that can start in any joint of the body, but most commonly begins in the smaller joints in the fingers, hands and wrists. Unlike osteoarthritis, the "wear and tear" arthritis and most common form of arthritis, RA is an autoimmune disease and occurs when the body's immune system malfunctions, attacking healthy joints. Major symptoms include joint pain, stiffness and swelling. RA affects approximately 1.3 million people in the U.S. and 1 percent of the adult population worldwide.

About DE019DE019 was a Phase 3, randomized, placebo-controlled trial in which patients with long-standing RA and an inadequate response to MTX were randomized to one year of HUMIRA 40 mg every other week (ADA-40), HUMIRA 20 mg weekly (ADA-20) or placebo injections; all received concomitant MTX. The primary endpoints were ACR 20 response rate at 6 months, change in HAQ and change in mTSS at week 52.  Results of this trial demonstrated the clinical, functional and radiographic superiority of HUMIRA plus MTX over placebo plus MTX.

About OPTIMAOPTIMA was a multicenter, randomized, double-blind, 78-week two-period study that enrolled 1,032 MTX-naïve patients age 18 or older with early (less than one year) moderate to severe RA. In period 1, patients were randomized to receive the combination of HUMIRA 40 mg every other week (eow) and MTX or placebo and MTX for 26 weeks.  Patients in the combination therapy arm who achieved the target (defined as LDAS, DAS28<3.2) at week 22 and 26 were blindly re-randomized to receive either MTX alone (treatment arm 1) or continued combination therapy (treatment arm 2) in period 2. Patients in the initial placebo plus MTX group who achieved the target at weeks 22 and 26 continued to receive MTX monotherapy (treatment arm 4) in a blinded fashion in period 2. Patients failing to achieve the target at weeks 22 and 26 received open-label combination therapy regardless of initial treatment assignment (treatment arms 3 and 5).

The primary endpoint of the study was a composite response of LDAS (DAS28<3.2) and no radiographic progression (change in mTSS < or = to 0.5) at week 78 in patients who continued the combination of HUMIRA and MTX versus those who continued on MTX monotherapy (arms 2 and 4). Significantly more patients who achieved the initial target response in period 1 and who continued on HUMIRA + MTX achieved the composite outcome of a LDAS and no radiographic progression at week 78 compared with those that achieved the initial target with placebo and MTX in period 1 and continued to receive placebo + MTX.

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